EUCTR2005-002826-70-ES进行中（未招募）1 期
Phase 2, open label, single arm study to evaluate the efficacy, safety, tolerability and pharmacokinetics of Ticilimumab in patients with advanced refractory and/or relapsed melanomaEstudio de fase II, abierto, de un sólo brazo para evaluar la eficacia, seguridad, tolerabilidad y farmacocinética de ticilimumab en pacientes con melanoma avanzado refractario y/o recurrrente
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Pfizer, S.A.
- 入组人数
- 215
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •To be eligible for the study, patients must satisfy all of the following criteria:
- •1. Histologically confirmed melanoma that is surgically incurable and either:
- •Stage III melanoma (AJCC 6th edition) including locally relapsed, in-transit lesions or draining nodes OR
- •Stage IV melanoma (M1a, M1b or M1c).
- •2. Prior treatment must include one, and not more than one, systemic therapy for the treatment of metastatic disease. Prior (first-line) systemic regimen for the treatment of metastatic melanoma must contain interleukin-2, dacarbazine and/or temozolamide or interfero-alfa. Patient must have received at least one cycle at full dose.
- •3. Documented disease progression after the last dose of prior therapy. Previously treated patients will include patients whose disease progressed during previous treatment (refractory), recurred following previous treatment (relapsed) or patients who could not tolerate previous treatment due to unacceptable toxicity and subsequently progressed.
- •4. A minimum of one measurable lesion according to Response Evaluation Criteria in SolidTumors (RECIST). Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension with longest diameter more than equal to 2.0 cm using conventional techniques or diameter =1.0 cm with spiral CT scan. If the measurable disease is restricted to a solitary lesion, its neoplastic nature must be confirmed by cytology or histology. Clinically detected lesions will only be considered measurable when they are superficial (eg, skin nodules) and the longest diameter is = 2 cm. Palpable lymph nodes = 2.0 cm should be demonstrable by CT scan. Tumor lesions that are situated in a previously irradiated area will be considered measurable if progression is documented following completion of radiation therapy.
- •NOTE: As a point of clarification for this study, skin lesion(s) selected as target lesionswill be accurately measured, and longest diameter will be at least 1.0 cm. Care should be exercised during biopsy procedures to prevent the alteration of the longest diameter of the selected skin lesion(s). Documentation by color photography, including a ruler to document the size of the target lesion(s), is required.
- •5. ECOG performance status (PS) 0 or 1.
- •6. Age =18 years.
- •7. Adequate bone marrow, hepatic, and renal function determined within 14 days prior to enrollment, defined as:
- •Absolute neutrophil count =1.5 x 9 to the power of 10 cells/L
- •Platelets =100 x 9 to the power of 10/L
- •Hemoglobin =10 g/dL
- •Aspartate and alanine aminotransferases (AST, ALT) less than equal to 2.5 x ULN (less than equal to 5 x ULN, if documented liver metastases are present)
- •Total bilirubin less than equal to 2 x ULN (except patients with documented Gilbert’s syndrome)
- •Serum creatinine less than equal to 2 mg/dL or calculated creatine clearance more than equal to 60 mL/min.
- •Serum lactic acid dehyrdrogenase (LDH) less than equal to 2 x ULN
- •9. Patients must have recovered from all prior treatment-related toxicities, to baseline status, or to NCI CTCAE (v 3.0) Grade of 0 or 1, except for toxicities not considered a safety risk such as alopecia or residual peripheral neuropathy resulting from prior systemic therapy. Post-surgical pain shall not be considered a basis for exclusion.
- •10. Must be willing and able to provide written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for
排除标准
- •Patients presenting with any of the following will not be included in the study:
- •1. Diagnosed with melanoma of ocular origin.
- •2. Received treatment for cancer, including immunotherapy, within one month prior to enrollment (dosing).
- •3. Received any prior vaccine therapy for the treatment of melanoma.
- •4. Received any prior CTLA4-inhibiting agent.
- •5. Previously randomized to Pfizer study A3671009: A Phase 3, Open Label, RandomizedComparative Study of Ticilimumab and Either Dacarbazine or Temazolamide in Patients with Advanced Melanoma.
- •6. History of, or significant evidence of risk for, chronic inflammatory or autoimmune disease (eg, Addison’s disease, multiple sclerosis, Graves disease, Hashimoto’s thyroiditis, inflammatory bowel disease, psoriasis, rheumatoid arthritis, systemic lupus erythematosus, hypophysitis, pituitary disorders, etc.). Active vitiligo or a history of vitiligo will not be a basis for exclusion.
- •7. History of, or clinically apparent hepatitis B or hepatitis C.
- •8. History of inflammatory bowel disease, celiac disease, or other chronic gastrointestinal conditions associated with diarrhea or bleeding, or current acute colitis of any origin.
- •9. History of uveitis or melanoma-associated retinopathy.
- •10. Potential requirement for systemic corticosteroids or concurrent immunosuppressive drugs based on prior history or received systemic steroids within the last 4 weeks prior to enrollment (Note: inhaled or topical steroids in standard doses are allowed.)
- •11. Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol.
- •12. Any serious, uncontrolled medical disorder or active infection which would impair their ability to receive study treatment.
- •13. Brain metastases. Radiological documentation of absence of brain metastases at screening is required for all patients.
研究者
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